BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX

    MDR report key: 6936196 · Received October 10, 2017

    Report

    Report Number
    9615742-2017-05478
    Event Type
    Injury
    Date Received
    October 10, 2017
    Report Date
    December 19, 2019
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    UDI-DI
    20884521176437
    PMA / PMN Number
    K101519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS RECEIVED AS A PART OF AN EXTENSIVE MESH LITIGATION SUBMISSION TO MEDTRONIC. THE FDA WAS NOTIFIED OF THIS LARGE COMPLAINT RECEIPT. DUE TO THE VOLUME OF COMPLAINT INFORMATION RECEIVED BY MEDTRONIC, THIS RESULTED IN A REPORT BEYOND THE 30 DAY TARGET. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS RECEIVED AS A PART OF AN EXTENSIVE MESH LITIGATION SUBMISSION TO MEDTRONIC. THE FDA WAS NOTIFIED OF THIS LARGE COMPLAINT RECEIPT. DUE TO THE VOLUME OF COMPLAINT INFORMATION RECEIVED BY MEDTRONIC, THIS RESULTED IN A REPORT BEYOND THE 30 DAY TARGET. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, DENSE ADHESIONS, CHRONIC PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, EXCISION OF MESH, REPAIR OF HERNIA WITH SYNOVIS/BARD PHASIX MESH, LYSIS OF ADHESIONS. CONCOMITANT THERAPY: SYNOVIS, LOT# 5780031-1520012, REF# (B)(4).

    Description of Event or Problem · 1

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF VENTRAL HERNIA. IT WAS REPORTED THAT AFTER UNDERLAY IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, DENSE ADHESIONS, CHRONIC PAIN, DIASTASIS OF THE RECTUS MUSCLE, AND SCAR TISSUE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERIES, EXCISION OF MESH, REPAIR OF HERNIA WITH SYNOVIS/BARD PHASIX MESH, LYSIS OF ADHESIONS. CONCOMITANT THERAPY: SYNOVIS, LOT#5780031-1520012, REF# (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PREOPERATIVE DIAGNOSIS WAS CHOLECYSTITIS WITH CHOLELITHIASIS AND LEFT INGUINAL HERNIA AND THE POSTOPERATIVE DIAGNOSIS WAS CHRONIC CHOLECYSTITIS WITH CHOLELITHIASIS, VENTRAL HERNIA, HYPERTROPHY OF XIPHOID PROCESS AND LEFT INGUINAL HERNIA. THE PROCEDURE PERFORMED WAS OPEN CHOLECYSTECTOMY, RESECTION OF HYPERTROPHIED XIPHOID PROCESS, OPEN REPAIR OF VENTRAL HERNIA WITH SYNOVIS UNDERLAY MESH AND OPEN REPAIR OF LEFT INGUINAL HERNIA USING MESH PLUG TECHNIQUE. THE PATIENT HAS HAD A MULTIPLE SURGICAL REVISION, RECURRENCE, REVISION/REMOVAL AND CHRONIC PAIN. CONCOMITANT THERAPY: SYNOVIS, LOT#5780031-1520012, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717150 PARIETEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS PNP8X3 SMG00774 20884521176437

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R